Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy

Abstract

The present invention provides compositions and methods for administering oxybutynin while minimizing the incidence and or severity of adverse drug experiences associated with oxybutynin therapy. In one aspect, these compositions and methods provide a lower plasma concentration of oxybutynin metabolites, such as N-desethyloxybutynin, which is presumed to be contributing at least in part to some of the adverse drug experiences, while maintaining sufficient oxybutynin plasma concentration to benefit a subject with oxybutynin therapy. The invention also provides isomers of oxybutynin and its metabolites that meet these characteristics of minimized incidence and / or severity of adverse drug experiences, and maintenance of beneficial and effective therapy for overactive bladder.

Description

PRIORITY DATA[0001] This patent application is a continuation of U.S. patent application Ser. No. 10 / 098,752, filed Mar. 15, 2002, which is a continuation of U.S. patent application Ser. No. 09 / 559,711, filed Apr. 26, 2000, each of which are incorporated herein by reference.[0002] The present invention relates to compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy. Accordingly, this invention covers the fields of pharmaceutical sciences, medicine and other health sciences.[0003] Oral oxybutynin is currently used for treating various forms of overactive bladder and urinary incontinence. Particularly, oxybutynin effectively treats neurogenically caused bladder disorders. Relief from such disorders is attributed to the anticholinergic and antispasmodic action which oxybutynin imparts to the parasympathetic nervous system and the urinary bladder detrusor muscle.[0004] It is generally believed that, while this anticholinergic activity contr...

AI Technical Summary

Problems solved by technology

In some cases, these adverse experiences are severe enough to persuade the patient to discontinue treatment.

However, due to their very short transit time through the mouth and the oral cavities, the release of drug from these formulations in the mouth or the oral cavity is considered de minimus or insubstantial.

The adverse drug experience may lead to a substantial disruption of a person's ability to conduct normal life functions.

In some instances, the adverse drug experience may be serious or life threatening.

While some of the adverse drug experiences may be expected, in some instances, such experiences may be unexpected.

Further, the oral dose results in a relatively large amount of (R)-N-desethyloxybutynin, the moiety most likely to be responsible for causing some or many of the adverse drug experiences.

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